Trial · NCT02299336
Long-Term Efficacy & Safety of Aflibercept IVT for the Treatment of DME in Subjects Who Completed the VISTA-DME Trial
NCT02299336, Phase 4, Completed, Greater Houston Retina Research; results first posted 2018-06-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Long-Term Efficacy & Safety of Aflibercept IVT for the Treatment of DME in Subjects Who Completed the VISTA-DME Trial. Trials, record NCT02299336. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02299336
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long-Term Efficacy & Safety of Aflibercept IVT for the Treatment of DME in Subjects Who Completed the VISTA-DME Trial
- NCT number
- NCT02299336
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 60 participants, actual
- Lead sponsor
- Greater Houston Retina Research
- Conditions
- Diabetic Macular Edema
- Interventions
- Aflibercept, Focal Laser
- First posted
- 2014-11-24
- Last updated
- 2019-06-04
- Results first posted
- 2018-06-07
- Limitations and caveats
Limitations of the ENDURANCE study include the small population and employment of aflibercept re-treatment criteria that allowed physicians to use their varying clinical judgement in determining anti-VEGF re-treatment instead of a strict protocol.
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Number of Intravitreal Aflibercept Injections for Subjects Who Were Enrolled and Completed the 3-year VISTA DME (VGFT-OD-1009) Trial | Week 104 | Measured by evaluating mean number of injections required for subjects who were enrolled and completed the 3-year VISTA DME (VGFT-OD-1009) trial |
| Secondary | Mean Change in Early Treatment Diabetic Retinopathy Study Best-corrected Visual Acuity From Baseline to Week 52 and Baseline to Week 104 | Week 52, Week 104 | Evaluate the mean change over time in Early Treatment Diabetic Retinopathy Study best-corrected visual acuity at week 52 from baseline and at week 104 from baseline. Participants were challenged with reading letters on lines of an eye chart (5 letters per line) in standardized lighting conditions. Lines became smaller as participants progressed from the top to the bottom of the chart. Participants read down the chart until they reached a row where a minimum of three letters on a line could be read, and were scored by how many letters could be correctly identified. |
| Secondary | Mean Number of Intravitreal Aflibercept Injections Before and After Receiving First Focal Laser Application. | Before First Focal Laser Treatment (FLT) at Week 12 or later; After First FLT at up to 104 weeks | Measure the role of focal laser treatment (fluorescein angiography-guided, if applicable) in decreasing the treatment burden among subjects who require ongoing aflibercept treatment in the management of diabetic macular edema. |
| Secondary | Percentage of Subjects With Gain or Loss of 0 to 5 Early Treatment Diabetic Retinopathy Study Best-corrected Visual Acuity Letters From Baseline to Week 52 and Baseline to Week 104 | Week 52, Week 104 | Evaluate the percentage of subjects with a gain or loss in Early Treatment Diabetic Retinopathy Study best-corrected visual acuity letters in patients treated with aflibercept from baseline to week 52 and baseline to week 104 |
| Secondary | Mean Change in Central Retinal Thickness From Baseline to Week 52 and Baseline to Week 104. | Week 52, Week 104 | Evaluate the mean change in central retinal thickness from baseline to week 52 and baseline to week 104 in patients treated with aflibercept. |
| Secondary | Number of Subjects With no Clinically-relevant Diabetic Macular Edema (as Defined in the Protocol) on Spectral Domain Optical Coherence Tomography From Baseline to Week 52 and Baseline to Week 104. | Week 52, Week 104 | Evaluate the number of subjects with no clinically-relevant diabetic macular edema (as defined in the protocol) on spectral domain optical coherence tomography from baseline to week 52 and baseline to week 104 in patients treated with aflibercept. |
| Secondary | Number of Subjects With Stable, Worsened, or Improved Diabetic Retinopathy | Week 52, Week 104 | Number of subjects with stable, worsened, or improved diabetic retinopathy through 104 weeks. |
| Secondary | Number of Subjects That Receive Focal Laser Treatment. | Week 52, Week 104 | Number of subjects that receive focal laser treatment from baseline to week 52 and from baseline to week 104. |
| Secondary | Mean Change in Early Treatment Diabetic Retinopathy Study Best-corrected Visual Acuity Before and After Focal Laser Therapy | 104 weeks | Evaluation of the effect of laser on Early Treatment Diabetic Retinopathy Study best-corrected visual acuity outcomes. Participants were challenged with reading letters on lines of an eye chart (5 letters per line) in standardized lighting conditions. Lines became smaller as participants progressed from the top to the bottom of the chart. Participants read down the chart until they reached a row where a minimum of three letters on a line could be read, and were scored by how many letters could be correctly identified. |
| Secondary | Mean Change in Central Retinal Thickness Before and After First Focal Laser Treatment | 104 weeks | Evaluate the mean change in central retinal thickness before and after first focal laser treatment in patients treated with pro re nata aflibercept. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Number of Intravitreal Aflibercept Injections for Subjects Who Were Enrolled and Completed the 3-year VISTA DME (VGFT-OD-1009) Trial | Week 104 | injections | MEAN | |
| SECONDARY | Mean Change in Early Treatment Diabetic Retinopathy Study Best-corrected Visual Acuity From Baseline to Week 52 and Baseline to Week 104 | Week 52, Week 104 | All participants were included in analysis. Due to participant attrition, missed visits, and variable follow-up intervals, the population analyzed at each time point is equal to or smaller than the population still enrolled at that time point. | letters | MEAN |
| SECONDARY | Mean Number of Intravitreal Aflibercept Injections Before and After Receiving First Focal Laser Application. | Before First Focal Laser Treatment (FLT) at Week 12 or later; After First FLT at up to 104 weeks | Only participants who were eligible for focal laser treatment were analyzed. | Injections | MEAN |
| SECONDARY | Percentage of Subjects With Gain or Loss of 0 to 5 Early Treatment Diabetic Retinopathy Study Best-corrected Visual Acuity Letters From Baseline to Week 52 and Baseline to Week 104 | Week 52, Week 104 | All participants were included in analysis. Due to participant attrition, missed visits, and variable follow-up intervals, the population analyzed at each time point is equal to or smaller than the population still enrolled at that time point. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Change in Central Retinal Thickness From Baseline to Week 52 and Baseline to Week 104. | Week 52, Week 104 | All participants were included in analysis. Due to participant attrition, missed visits, and variable follow-up intervals, the population analyzed at each time point is equal to or smaller than the population still enrolled at that time point. | Microns | MEAN |
| SECONDARY | Number of Subjects With no Clinically-relevant Diabetic Macular Edema (as Defined in the Protocol) on Spectral Domain Optical Coherence Tomography From Baseline to Week 52 and Baseline to Week 104. | Week 52, Week 104 | All participants were included in analysis. Due to participant attrition, missed visits, and variable follow-up intervals, the population analyzed at each time point is equal to or smaller than the population still enrolled at that time point. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Stable, Worsened, or Improved Diabetic Retinopathy | Week 52, Week 104 | All participants were included in analysis. Due to participant attrition, missed visits, and variable follow-up intervals, the population analyzed at each time point is equal to or smaller than the population still enrolled at that time point. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects That Receive Focal Laser Treatment. | Week 52, Week 104 | All participants were included in analysis. Due to participant attrition, missed visits, and variable follow-up intervals, the population analyzed at each time point is equal to or smaller than the population still enrolled at that time point. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Change in Early Treatment Diabetic Retinopathy Study Best-corrected Visual Acuity Before and After Focal Laser Therapy | 104 weeks | All participants receiving laser were included in analysis. | letters | MEAN |
| SECONDARY | Mean Change in Central Retinal Thickness Before and After First Focal Laser Treatment | 104 weeks | All participants were included in analysis. Due to participant attrition, missed visits, and variable follow-up intervals, the population analyzed at each time point is equal to or smaller than the population still enrolled at that time point. | microns | MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group23
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Number of Intravitreal Aflibercept Injections for Subjects Who Were Enrolled and Completed the 3-year VISTA DME (VGFT-OD-1009) Trial | PRN (Pro re Nata) | 9.5 | Standard Error 6.7 | injections | |
| Mean Change in Early Treatment Diabetic Retinopathy Study Best-corrected Visual Acuity From Baseline to Week 52 and Baseline to Week 104 | PRN (Pro re Nata) | 52 Weeks | 0.61 | Standard Error 1.28 | letters |
| Mean Change in Early Treatment Diabetic Retinopathy Study Best-corrected Visual Acuity From Baseline to Week 52 and Baseline to Week 104 | PRN (Pro re Nata) | 104 Weeks | 0.83 | Standard Error 1.66 | letters |
| Mean Number of Intravitreal Aflibercept Injections Before and After Receiving First Focal Laser Application. | PRN (Pro re Nata) | Injections Before First Focal Laser | 7.5 | Standard Deviation 3.7 | Injections |
| Mean Number of Intravitreal Aflibercept Injections Before and After Receiving First Focal Laser Application. | PRN (Pro re Nata) | Injections After First Focal Laser | 6.7 | Standard Deviation 4.2 | Injections |
| Percentage of Subjects With Gain or Loss of 0 to 5 Early Treatment Diabetic Retinopathy Study Best-corrected Visual Acuity Letters From Baseline to Week 52 and Baseline to Week 104 | PRN (Pro re Nata) | Week 52 | 35 | Participants | |
| Percentage of Subjects With Gain or Loss of 0 to 5 Early Treatment Diabetic Retinopathy Study Best-corrected Visual Acuity Letters From Baseline to Week 52 and Baseline to Week 104 | PRN (Pro re Nata) | Week 104 | 30 | Participants | |
| Mean Change in Central Retinal Thickness From Baseline to Week 52 and Baseline to Week 104. | PRN (Pro re Nata) | Week 52 | -7 | Standard Error 8.6 | Microns |
| Mean Change in Central Retinal Thickness From Baseline to Week 52 and Baseline to Week 104. | PRN (Pro re Nata) | Week 104 | 1 | Standard Error 11.53 | Microns |
| Number of Subjects With no Clinically-relevant Diabetic Macular Edema (as Defined in the Protocol) on Spectral Domain Optical Coherence Tomography From Baseline to Week 52 and Baseline to Week 104. | PRN (Pro re Nata) | Week 52 | 39 | Participants |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PRN (Pro re Nata) | 60 | |
| Overall Study | COMPLETED | PRN (Pro re Nata) | 46 | |
| Overall Study | NOT COMPLETED | PRN (Pro re Nata) | 14 |
Source ClinicalTrials.gov
Adverse events41
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Vitreous hemorrhage | Eye disorders | PRN (Pro re Nata) | 9 | 60 | |
| other | Neovascularization elsewhere | Eye disorders | PRN (Pro re Nata) | 2 | 60 | |
| other | Neovascularization of the disc | Eye disorders | PRN (Pro re Nata) | 1 | 60 | |
| other | Worsening cataract | Eye disorders | PRN (Pro re Nata) | 8 | 60 | |
| other | Corneal abrasion | Eye disorders | PRN (Pro re Nata) | 1 | 60 | |
| other | Subconjunctival hemorrhage | Eye disorders | PRN (Pro re Nata) | 1 | 60 | |
| other | Superficial punctate keratitis | Eye disorders | PRN (Pro re Nata) | 1 | 60 | |
| other | Eye swelling post-cataract extraction | Eye disorders | PRN (Pro re Nata) | 1 | 60 | |
| other | Posterior vitreous detachment | Eye disorders | PRN (Pro re Nata) | 1 | 60 | |
| other | Floaters | Eye disorders | PRN (Pro re Nata) | 5 | 60 |
1 to 10 of 41Source ClinicalTrials.gov
See all 41 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PRN (Pro re Nata) | 1 | 60 |
| Total, other adverse events | PRN (Pro re Nata) | 26 | 60 |
| Total, serious adverse events | PRN (Pro re Nata) | 19 | 60 |
Source ClinicalTrials.gov
Papers14
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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